Clinical Research Medical Director, Bone

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-16662
Amgen remains focused on bone health and making strides in the development of molecules for osteoporosis and other bone diseases. Prolia and Romosozumab are two of the molecules within this team.
The Bone and Nephrology TA is seeking a physician for their Bone Clinical Development Team member whose responsibilities will include:
Supporting the development, execution and communication of the global scientific/medical evidence generation plan.
Participating and providing clinical input into safety and regulatory interactions during the development and execution of clinical trials, interpretation of data, preparation of safety and interactions with regulatory agencies including submissions.
Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program including scientific presentation at advisory boards, key scientific meetings and external committee meetings
Lead the identification of new clinical research opportunities
Basic Qualifications
Two (2) + years of clinical research experience and/or basic science research
Preferred Qualifications
Accredited residency in relevant sub-specialty (endocrinology, rheumatology, or internal medicine), board certified or equivalent
Five (5) + years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in the endocrinology and/or rheumatology area
Familiarity with concepts of clinical research and clinical trial design, including biostatistics
Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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